Dimethylfumarat (Skilarence, 1) – Skilarence®
Plaque psoriasis (PP)
Characteristics
| Start date | 01.10.2017 – Marketing authorisation: 23.06.2017 |
|---|---|
| Resolution | 16.03.2018 |
| INN | Dimethylfumarat |
| Brand name | Skilarence® |
| Pharm. company | Almirall Hermal GmbH |
| G-BA Procedure ID | D-316 |
| ATC code | D05BX02 Other antipsoriatics for systemic use (D05BX) |
| ICD-10 codes (AIS) | L40.0Nummular psoriasis |
| Alpha-ID codes (AIS) | I109655Plaque psoriasis |
| DDD | 0.36 g O |
| Therapeutic area | Skin diseases Plaque psoriasis (PP) |
| Reason for procedure | New therapeutic indication |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
|---|
|
Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| A) | Treatment of adult patients with moderate to severe psoriasis vulgaris who require systemic drug therapy. | Fumarsäureester oder Ciclosporin oder Methotrexat oder Secukinumab |
| B) | Treatment of adult patients with moderate to severe psoriasis vulgaris who have an inadequate response to other systemic therapies (ciclosporin, methotrexate or psoralen and ultraviolet A light) or who have a contraindication. | Adalimumab or infliximab or secukinumab or ustekinumab |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (BRIDGE) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Patient eligibility |
| ACT change | 15.09.2017 – Marktrücknahme Methoxsalen |
- Clinical trials
- Although the pharmaceutical manufacturer identified the BRIDGE trial comparing dimethyl fumarate with fumaric acid esters, it did not take this into account when assessing the additional benefit due to the short treatment duration of 16 weeks.
a) adult patients with moderate to severe psoriasis vulgaris who require systemic drug therapy
- An additional benefit is not proven.
- The pharmaceutical manufacturer has not provided any data for patient population A, which is the subject of this assessment; consequently, no conclusions can be drawn regarding the additional benefit of dimethyl fumarate.
- No additional benefit is therefore proven.
b) adult patients with moderate to severe psoriasis vulgaris who have had an inadequate response to other systemic therapies, including ciclosporin, methotrexate or oral PUVA (psoralen and ultraviolet A light) or who have a contraindication to or are intolerant of such therapies
- An additional benefit is not proven.
- The pharmaceutical manufacturer has not provided any data for patient population B under assessment; consequently, no conclusions regarding the additional benefit of dimethyl fumarate can be drawn.
- An additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Dimethylfumarat (Skilarence, 1) | Skilarence® | Almirall Hermal GmbH | Plaque psoriasis (PP) | 52,200–234,100 | 100% additional benefit not proven |
<< List of all resolutions